Kornimate/medical-research-clean huggingface dataset:
decitabine plus mbu/cy preconditioning for relapse/refractory acute leukemia

Conditions: Stem Cell Transplant Complications; Relapse Leukemia; Refractory Leukemia

Summary: allogeneic haematopoietic stem cell transplantation (allo-hsct) remains one of the currently available curative therapies for acute leukemia (al). leukemia relapse is one of the mainly causes of transplant failure. we reported previously that patients with relapse or refractory al were at very high risk of relapse post allo-hsct, with cumulative relapse rate of 50-80%. decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. it was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-hsct using hla-matching donors was safe and effective. in this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mbu/cy) as a preparative regimen for allo-hsct in recurrent and refractory al patients.

patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-hsct. the conditioning therapy for human leukocyte antigen (hla)-mismatched hsct patients was modified bu/cy plus atg (thymoglobulin; sang stat, france) consisting of cytarabine (ara-c 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (bu 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (cy 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (me-ccnu, 250 mg·m-2), orally once on day -3, and atg (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. in matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of ara-c (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the hla-mismatched patients without atg. bm(bone marrow) samples from patients were obtained to assess leukemia status after hsct. the time points that we monitored bm samples included at time of allo-hsct; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-hsct; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation.

Eligibility criteria:
inclusion criteria: * patients with relapsed acute leukemia * patients with acute leukemia in the third（or more）complete remission (cr3) status exclusion criteria: * pregnancy women * uncontrolled severe infection

Keywords: recurrent acute leukemia refractory acute leukemia preconditioning regimen allogeneic stem cell transplantation
real-world outcome of rheumatoid arthritis patients in korea on adalimumab

Conditions: Rheumatoid Arthritis

Summary: the study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (qol) and work productivity in patients with rheumatoid arthritis (ra) in korea.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of ra as defined by the 1987 revised american college of rheumatology (acr) classification criteria and/or the acr/the european league against rheumatism (eular) 2010 classification criteria (any duration since diagnosis). * male or female subject ≥ 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label. * patients with moderate to severe ra defined as disease activity score in 28 joints (das28) (esr) or das28 (crp) \> 3.2 * biologically treatment naïve and initiated adalimumab at baseline visit * availability of clinical data of the previous 12 weeks prior to baseline * ability to self-complete patient questionnaires * subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol. exclusion criteria: * patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks. * participation in any ra-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline * patients who in the clinician's view, may not be able to accurately report their qol or prior resource utilization * patients who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.

Keywords: rheumatoid arthritis work productivity patient-reported qol(quality of life)
stress biomarkers among patients undergoing treatment for excited delirium and severe pain in the emergency department

Conditions: Agitation; Excited Delirium; Pain

Summary: the purpose of this project is to determine the levels of stress biomarkers associated with severe pain, agitation from intoxication or psychosis, and excited delirium at various levels of the disease in order to compare them to pre-clinical models of law enforcement encounters. we hypothesize that the serum catecholamines and markers of metabolic acidosis will worsen with the duration and severity of agitation among agitated patients and will not worsen among patients with severe pain who are not agitated. specific aims * to assess the prevalence of patients undergoing treatment for agitation from any cause requiring restraint or sedation. * to assess the prevalence of excited delirium in the emergency department. * to determine the difference in serum total catecholamines, serum dopamine, serum epinephrine, serum norepinephrine, heart rate, systolic blood pressure, mean arterial pressure, mortality, and disposition among patients with agitation requiring restraint, including excited delirium and patients with severe pain from extremity fractures. * to describe changes in stress biomarkers among patients with changing levels of agitation as determined by the altered mental status scale.

in this study, we propose to study emergency department patients under physiologic stress from severe pain, agitation, drug overdose, and excited delirium in order to compare markers of acidosis in patients at risk for unexplained-in-custody-death (uicd) in order to determine the relationship of these markers to what has been found in simulated law enforcement encounters. this information will help clarify the levels of stress associated with arrest and restraint conditions, allowing us to determine what aspects and levels of stress may be associated with the fatal mechanisms of uicd, and to identify markers that would inform death investigators of the mechanism of uicd. at the conclusion of this project, we will be able to report details explaining the relationship of the physiologic and metabolic effects of stress from restraint in excited delirium to other peri-arrest conditions and our previous work in simulated law enforcement encounters.

Eligibility criteria:
agitation group inclusion criteria: * patients with agitation as defined by an altered mental status score of \>1, and who are in restraints or are given sedatives for treatment of agitation. agitation group exclusion criteria: * less than 18 years of age * suspected or confirmed pregnancy pain group inclusion criteria: * patients with an extremity fracture who report their pain as severe. pain group exclusion criteria: * less than 18 years of age * suspected or confirmed pregnancy * prisoner

Keywords: agitation excited delirium pain unexplained-in-custody-death uicd visual analog scale vas altered mental status ams
systemic fungal infections in icu patients

Conditions: Fungal Infection

Summary: this study aims to : 1. diagnosis of systemic fungal infections in icu patients. 2. detection the most common fungal species in icu. 3. detection of in vitro antifungal sensitivity pattern

systemic fungal infections are a significant and growing public health problem ,over the past few years, major advances in healthcare have led to an unwelcome increase in the number of life-threatening infections due to true pathogenic and opportunistic fungi ,these have a significant impact on morbidity, mortality, length of hospital stay, and healthcare costs in critically ill patients in intensive care unit ( icu). health care workers encounter at risk patients in icu in various settings : including diabetes mellitus, renal insufficiency, surgery (especially abdominal surgery), the use of broad-spectrum antibiotics, parenteral nutrition, hemodialysis, mechanical ventilation, the presence of central vascular catheters, and therapy with immunosuppressive agents,prolonged treatment with corticosteroids before icu admission, liver cirrhosis with prolonged icu stay (.7 days), solid organ cancer, hiv infection and lung transplantation are also considered as risk factors ,it can also occur following trauma or invasion of wounds covered with contaminated dressings, e.g. in the icu. one outbreak of gastric mucormycosis in icu patients reported in spain arose in association with the use of contaminated wooden tongue depressors in critically ill patients. candida and aspergillus species are the most frequent causes of healthcare-associated fungal infections in these patients, although candida infections are the most frequent fungal infections in icu patients, invasive aspergillosis is associated with higher morbidity and mortality rates even in the absence of traditional risk factors,invasive candidiasis is a highly lethal infection associated with mortality rates between 40 and 60 %. the five most common candida species are candida albicans, candida glabrata, candida tropicalis, candida parapsilosis, and candida krusei. accurate diagnosis of invasive fungal infection is crucial so that appropriate antifungal agents can be started rapidly. however, early diagnosis is not always easy. microscopic examination is rapid and can be helpful but a negative result does not exclude infection. blood cultures are positive in only 50-70 % of cases of candida bsi, furthermore, it can take several days before candida is identified at the species level and antifungal susceptibility data are available but remain the gold stander in diagnosis.

Eligibility criteria:
inclusion criteria: * suppressed immunity such as: (patients with malignancy under chemotherapy, prolonged use of corticosteroids..........etc) * manifestations of chest infection e.g.cough, haemoptysis, dyspnea and chest discomfort. * persistent fever resistant to antibiotic therapy. * urinary manifestations resistant to antibiotic therapy. exclusion criteria: * patients who received antifungal therapy within 3 days prior to sample collection. * patients refused to participate in the study.
extended use of cannabidiol for the prevention of graft-versus-host-disease

Conditions: Graft vs Host Disease

Summary: cannabidiol (cbd), a non-psychotropic ingredient of cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. in a recent prospective phase ii study (nct01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given cbd 300 mg/day starting 7 days before transplantation until day 30, on top of standard gvhd prophylaxis consisting of cyclosporine and a short course of methotrexate. there were no grade 3-4 toxicities attributed to cbd. none of the patients developed acute gvhd while consuming cbd. with a median follow-up of 16 months, the cumulative incidence rates of grade 2-4 and grade 3-4 acute gvhd by day 100 were 12.1% and 5%, respectively. compared to 101 historical control subjects given standard gvhd prophylaxis, the hazard ratio of developing grade 2-4 acute gvhd among subjects treated with cbd plus standard gvhd prophylaxis was 0.3 (p=0.0002). among patients surviving more than 100 days, the cumulative incidence of moderate-to-severe chronic gvhd at 12 and 18 months were 20% and 33%, respectively. the aim of this study is to explore the safety and efficacy of extended use of cbd until day 100 in the prevention of acute and chronic gvhd.


Eligibility criteria:
inclusion criteria: 1. acute leukemia in complete remission 2. myeloablative conditioning 3. matched or one antigen or allele mismatched sibling or unrelated donor exclusion criteria: 1. history of psychosis 2. bronchial asthma
role of airtraq mobile to improve intubation conditions with airtraq

Conditions: Nasal Obstruction; Arthrosis

Summary: airtraq sp has been proven effective for intubating patients presenting with difficult airway. the airtraq sp allows visualisation of the tracheal inlet only for the intubator. by adding a smartphone with a dedicated app (airtraq mobile) to the airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers. the investigators aim to demonstrate that the addition of the airtraq mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients.

airtraq sp has been proven effective for intubating patients presenting with difficult airway. the airtraq sp allows visualisation of the tracheal inlet only for the intubator. by adding a smartphone with a dedicated app (airtraq mobile) to the airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers. the investigators aim to demonstrate that the addition of the airtraq mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients while their neck is imobilized by a cervical collar, creating a simulated difficult airway. patients will be included if they necessitate an elective general anesthesia and orotracheal intubation. exclusion criteria are related to difficult airway, asa iv and patient refusal.

Eligibility criteria:
inclusion criteria: * american society of anesthesia classification 1-3, elective surgey necessitating general anesthesia and intubation, patient consent exclusion criteria: * american society of anesthesia classification 4, patient refusal, history of difficult airway

Keywords: intubation airtraq general anesthesia difficult airway
comparative study between topical 5-fluorouracil and latanoprost in vitiligo.

Conditions: Vitiligo

Summary: this study aims to compare the efficacy of topical 5-fluorouracil versus topical latanoprost after skin microneedling in the induction of skin repigmentation in localized stable vitiligo patients.

vitiligo is an acquired pigmentary disorder characterized by depigmented macules and patches secondary to the loss of functional melanocytes. it is a chronic disease that affects between 0.1% and 2% of the general population, affecting both sexes and all races. theories regarding loss of melanocytes are based on autoimmune, cytotoxic, oxidant-antioxidant and neural mechanisms. therapeutic strategies for vitiligo include nonsurgical and surgical methods. nonsurgical options include topical corticosteroids and topical calcineurin inhibitors. phototherapy as psoralen and ultraviolet a (puva) and narrow-band ultraviolet b (nb-uvb). two types of surgical techniques are available: tissue grafts and cellular grafts, within between autologous cultured epithelial grafts. microneedling is a method of transdermal drug delivery using a microneedling device applied to the skin for creating transport pathways through the stratum corneum, increasing the absorption of drugs and decreasing the duration of therapy. in addition, microneedling keeps the epidermis partially intact, fastens recovery, and limits the risk of infection and scarring. 5-fluorouracil (5-fu) is a chemotherapeutic agent used in the treatment of many malignant tumors and it has been approved for topical use in the treatment of several dermatologic disorders. localized hyperpigmentation occurred as a side effect of 5-fu use in cancer treatment attracts the attention toward its application in inducing repigmentation in vitiligo patches. latanoprost (lt), a prostaglandin f2 alpha analogue used in the treatment of glaucoma, was found to induce skin pigmentation in guinea pigs in addition to its known periocular and iridal pigmentation side effect.

Eligibility criteria:
inclusion criteria: * patients of both sexes with stable localized vitiligo : patches should not have any increase or decrease in size or pigmentation for at least 3 months. exclusion criteria: * pregnant or lactating female. * active koebner's phenomenon. * age less than 10 years. * all patients included had not received any local or systemic medication for at least 2 months before the study. * keloidal tendency.
cortical neuroplasticity by muscle pain of pain-induced plasticity

Conditions: Nerve Growth Factor; Exercise; Motor Activity; Abnormality of SSEPs; Hyperalgesia

Summary: the purpose of this study is to investigate the sensory-motor cortical excitability response to delayed onset muscle soreness (doms) on extensor carpi radialis (ecr) muscle during muscle hyperalgesia provoked by nerve growth factor (ngf).

the purpose of this study is to assess changes in sensory-motor cortical excitability during experimental muscle hyperalgesia across several days provoked by injections of nerve growth factor (ngf) into the extensor carpi radialis (ecr) muscle and delayed onset muscle soreness (doms) of the ecr muscle. it was hypothesized that muscle hyperalgesia across several days would result in: i) increased sensory cortical excitability, based on somatosensory evoked potentials by means of electrical stimulation of the radial nerve, (increase of central-parietal evoked-potential p45 and decrease of frontal evoked-potential n30); ii) increased corticomotor excitability of a ecr (increase map volume and number of active sites), assessed as motor evoked potentials induced by transcranial magnetic stimulation in primary motor cortex (m1); iii) reduction of alpha oscillation based on nociceptive stimulus-evoked suppression of alpha activity in sensory regions (recording electrodes on contra-lateral parietal area);

Eligibility criteria:
inclusion criteria: * healthy men and women * speak and understand english. exclusion criteria:pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses * lack of ability to cooperate * history of chronic pain or current acute pain * previous experience with rtms * contraindications to rtms application (history of epilepsy, metal in the head or jaw etc.). * failure to pass the "tass questionnaire" (tass = transcranial magnetic stimulation adult safety screen)
feasibility of emotion regulation group therapy for adolescent self-harm

Conditions: Self-harm; Emotion Regulation; Adolescent - Emotional Problem

Summary: deliberate self-harm (dsh) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. emotion regulation group therapy (ergt) is a brief treatment for dsh with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present. a quantitative feasibility open trial (n=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ergt for adolescents.

deliberate self-harm (dsh) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. emotion regulation group therapy (ergt) is a brief treatment for dsh with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present. adaptations to ergt will result in a 12 session long treatment for adolescents emotion regulation group therapy for adolescents (ergt-a). a parallel parent group focused on strengthening parental skills will be given alongside ergt-a (5 sessions) method: a quantitative feasibility open trial (n=20) with pre, post and 1 month follow-up assessments will examine the feasibility, acceptability and preliminary effect of ergt for adolescents. feasibility measures include recruitment rate, proportion beginning treatment, attrition, treatment credibility and satisfaction, negative effects, and alliance. preliminary effects measures include dsh, emotion regulation ability, anxiety and depression. method: a qualitative interview study. using thematic analysis to explore participants' experience of ergt-a and parent group

Eligibility criteria:
inclusion criteria: 1. 13-17 years of age; 2. having engaged in deliberate self-harm (dsh)-behaviours ≥ 5 times the last year; 3. having engaged in ≥1 dsh episode during the past month; 4. having ongoing psychiatric treatment in the community; 5. having at least one caregiver or other significant adult, committed to participate in the parent program; and 6. stability of psychotropic medications exclusion criteria: 1. a diagnosis of psychotic, bipolar i disorder or severe social anxiety disorder (sad); 2. ongoing substance dependence; 3. the presence of co-occurring psychiatric disorders that require immediate treatment; 4. having an autism spectrum disorder together with borderline intellectual disability or having an intellectual disability; 5. insufficient understanding of the swedish language

Keywords: self-harm emotion regulation group treatment adolescents
augmented reality for subdural drain placement

Conditions: Subdural Hematoma

Summary: this study involves using a augmented reality (ar) system to assist in the placement of a subdural evacuating portal system (seps). in the first part of the study, all participants will have skin marking of an ar-guided and non-ar-guided site to determine feasibility and method accuracy. in the second part, subjects will be randomized to ar-guided and non-ar-guided seps placement to determine efficacy.

chronic/subacute subdural hematoma (sdh) is one of the most common diseases encountered in neurosurgical practice. however, there is little consensus on first-line treatment. the seps was developed to implement a minimally invasive approach to drainage. new imaging technologies, such as augmented reality (ar) interfaces, can provide anatomical models and can help visualize hidden structures. the hope is that this study can give insight on whether ar-guidance can be used to improve seps placement, which can lead to higher volume drainage, greater symptomatic improvement, and decreased hospital stay.

Eligibility criteria:
inclusion criteria: * unilateral or bilateral subdural hematoma that is planned to be treated by seps exclusion criteria * unable to have ct scan * pregnancy
specified drug-use survey of leqvio for s.c. injection.

Conditions: Familial Hypercholesterolaemia; Hypercholesterolaemia

Summary: the objective of this study is to evaluate the long-term safety of leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

uncontrolled, central registration system, multicenter, special drug use-results surveillance. this is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: nis) conducted only in japan. the survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with leqvio. patients who discontinued treatment with leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of leqvio plus 180 days or until 24 months after the first dose of leqvio, whichever comes earlier.

Eligibility criteria:
inclusion criteria: * patients who provided written informed consent to participate in this survey prior to the start of treatment with leqvio. * patients who received treatment with leqvio as per the package insert. exclusion criteria: * patients who received treatment with a formulation containing the same ingredients as leqvio in the past. * patients participating in other interventional studies at the time of informed consent. * patients planning to participate in other interventional studies during this survey.

Keywords: familial hypercholesterolaemia hypercholesterolaemia fh hofh leqvio inclisiran sodium